Empliciti® (elotuzumab)

EMPLICITI (elotuzumab) is a prescription medicine used to treat multiple myeloma in combination with the medicines REVLIMID® (lenalidomide) and dexamethasone, in people who have received one to three prior treatments for their multiple myeloma.

Unlike traditional chemotherapy treatments, EMPLICITI is a new type of immunotherapy that works with a patient’s own immune system to fight multiple myeloma. EMPLICITI works in 2 ways. It activates a key type of white blood cell in your immune system, called a Natural Killer (NK) Cell. EMPLICITI also identifies myeloma cells so they are more easily recognized by NK Cells. That way, activated NK Cells can find myeloma cells to destroy.

•For patients who have received 1-3 prior therapies.
•Given in combination with Revlimid and dexamethasone
•Binds to and enhances NK (natural killer) cells or immunity

–Antibody administration

•Risk of a temporary infusion reaction with first dose, but most are mild after premedication with dexamethasone and acetaminophen
•Initially infused at a slow rate and then escalated over time
•Give weekly for 8 weeks, then twice monthly

–Pearls

•Take aspirin for blood clot prevention (Revlimid)
•Infection prevention (wash hands, avoid colds and report symptoms)
•Take as long as it is working and if side effects are manageable

Bristol-Myers Squibb is committed to helping appropriate patients get access to our medications. That’s why we’ve created BMS Access Support®, to help you understand your insurance coverage and how you are going to pay for your medicine.

This booklet discusses the new drug Empliciti® (known also by its generic name, elotuzumab): the way it works, the results of clinical trials with Empliciti, how and when Empliciti is administered, the possible side effects of Empliciti, and how to manage those side effects.

Dose and Schedule

Empliciti™ (elotuzumab) is given as an intravenous (IV) infusion into a vein at a dose of 10 mg/kg of body weight. It is given along with Revlimid® (lenalidomide) and dexamethasone once a week for the first two cycles and every 2 weeks thereafter.

Possible Side Effects

Infusion reactions

Monoclonal antibodies entered the cancer-fighting armamentarium over a decade ago, but they are new to myeloma. Empliciti, like other monoclonal antibodies, is well tolerated and has no significant side effects that overlap with Revlimid + dexamethasone. Like many other mono-clonal antibodies, Empliciti may, however, cause infusion reactions, giving rise to a range of responses that may be caused by the release of cytokines. Infusion reac-tions, which can happen during the infusion or within 24 hours after an infusion of Empliciti, occurred in 10% of the patients who received Empliciti in the ELOQUENT-2 clinical trial, although 70% of those infu-sion reactions occurred only with the first dose. Infusion reactions with Empliciti, which are likely to be cytokine-mediated, subside with each subsequent dose. The most common infusion reactions were fever, chills, and elevated blood pres-sure (hypertension). There were no infu-sion reactions that were serious enough to require hospitalization, and only 2 out of 321 patients dropped out of the ELOQUENT-2 clinical trial because of an infusion reaction.

Lymphocytopenia and neutropenia

Patients may experience conditions called lymphocytopenia and neutrop-nia, which reflect a lowered level of lymphocytes and neutrophils (types of white blood cells). White blood cells help to fight infection. Too few white blood cells can lead to infections.

Anemia (low red blood cell count)

Red blood cells contain hemoglobin, a protein that contains iron and transports oxygen from the lungs to the body’s organs and tissues. When a patient has anemia, the result is low levels of oxygen in the body, which may cause shortness of breath and feelings of exhaustion. Anemia is not an immediate effect of Empliciti + Revlimid + dexamethasone, but one that may appear with duration of treatment.

Thrombocytopenia

Thrombocytopenia is a lowered level of platelets in the blood. Platelets help blood to clot; fewer platelets can lead to bruising, bleeding, and slower healing.

Diarrhea

Diarrhea may occur while taking Empliciti + Revlimid + dexamethasone. Dizziness, light-headedness, or fainting may occur due to dehydration caused by either excessive or persistent diarrhea.

Fever

Fever is defined as an oral temperature greater than 38°C or 100.4°F in a 24-hour period, or one temperature greater than 38.5°C or 101.3°F. When the white cell count is low, the body’s normal defenses against infections are down, and fever needs to be further evaluated immediately. In clinical trials with Empliciti, fevers likely arose from two causes: as a reaction to medication (from the release of cytokines, an immune response that causes flu-like symptoms) and/or from a bacterial or viral infection (from a low white cell count resulting in impaired immune response).

Constipation

Prevention is the key to managing constipation, which is defined as having fewer than three bowel movements a week. Chronic constipation is defined as infrequent bowel movements or difficult passage of stools that persists for several weeks or longer.

Infections

Infections as mild as a cold (an “upper respiratory tract infection”) or as severe as pneumonia can occur in people who receive Empliciti + Revlimid + dexamethasone. Cough, runny nose, and sore throat are all common side effects experienced by patients taking Empliciti + Revlimid + dexamethasone, and may be signs of an upper respiratory tract infection. The signs and symptoms of pneumonia vary depending on the type of germ causing the infection. Mild signs and symptoms are similar to those of a cold or flu, but they last longer.

Muscle spasms

Muscle spasms occur when a skeletal muscle contracts forcefully and involuntarily and does not relax. Leg muscles, especially the thighs, hamstrings, and calves, are most likely to contract, but any skeletal muscle in the body can cramp. Dehydration, electrolyte imbalance, and physical deconditioning may all cause muscle spasms, but they may also be related to neuropathy caused by treatment or arising from the myeloma itself.

Decreased appetite

There are many causes for loss of appetite during treatment with Empliciti + Revlimid + dexamethasone, including other side effects of treatment such as diarrhea and constipation. Lack of exercise, anxiety, depression, and pain can also be at the root of the problem. Good communication with your healthcare team members will help them understand how you’re feeling physically and mentally, and will help determine the source of your appetite loss.

ClinicalTrials.gov is a registry of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details. This information should be used in conjunction with advice from health care professionals.